Adaptive system for optimizing a drug dosage regimen over time

Abstract

A system for optimizing a patient's basal insulin dosage regimen over time, adapted to determine from blood glucose values whether and by how much to vary a patient's present recommended amount of the insulin-containing drug in order to maintain the patient's future blood glucose level measurements within a predefined range, and wherein a given blood glucose value is disregarded if no patient-actuated operation being indicative of the administration of a dose of an insulin containing drug has been detected in a pre-defined amount of time prior to the determination of the given blood glucose value.

The invention claimed is: 
     
       1. A drug delivery assembly comprising:
 (i) a memory structure adapted to receive data representing an initial basal insulin dosage regimen and fasting blood glucose values as a function of time over a period from m to n, wherein each of m and n is an integer representing a number of days; 
 (ii) a processor operatively connected to the memory structure and programmed to perform a titration process to obtain a new insulin titration dose; 
 wherein
     IU   Titration level ( n )= IU   Titration level ( n− 1)+Babystep( n ); 
   wherein 
   Babystep( n )= ISF   average ( n )*(Average FBG ( n )−Target FBG )* SF ( FBG   Variance ); and
 
 wherein
 IU Titration level (n) is the new insulin titration dose, 
 IU Titration level (n−1) is a previous insulin titration dose, 
 ISF average (n) is an average insulin sensitivity factor over the period from n−1 to n−m, 
 Average FBG (n) is an average fasting blood glucose over the period from n to n−m, 
 Target FBG  is a target fasting blood glucose level, and 
 SF(FBG Variance ) is a safety factor value that is a function of the variance of the fasting blood glucose, wherein the value is in the range of 0 to 1; and 
 
 
 (iii) an output structure adapted to communicate to the patient the new insulin titration dose; 
 (iv) an insulin reservoir or structure adapted to receive an insulin reservoir; 
 (v) an outlet for the insulin; and 
 (vi) an insulin expelling mechanism adapted to expel the new titration insulin dose from the reservoir and out through the device. 
 
     
     
       2. The drug delivery assembly according to  claim 1 , further comprising:
 a blood glucose meter structured to receive a patient blood sample and generate fasting blood glucose values as a function of time from patient blood samples; and 
 a transmission structure adapted to transmit the fasting blood glucose values as a function time to the memory structure. 
 
     
     
       3. The drug delivery assembly according to  claim 1 , further comprising:
 a detection structure adapted to detect when a patient-actuated operation is performed, wherein the operation is indicative of the administration of a dose of an insulin containing drug; wherein 
 the memory structure is further is adapted to receive data representing detected patient-actuated operations as a function of time, and 
 the processor is further programmed to calculate a compliance value based on the detected patient-actuated operations compared to a pre-defined schedule for the patient-actuated operations. 
 
     
     
       4. The drug delivery assembly according to  claim 3 ,
 wherein the detection structure is adapted to detect a cap-off event when the cap has been at least partially de-mounted from the drug delivery device for a pre-determined amount of time. 
 
     
     
       5. The drug device assembly according to  claim 3 , wherein
 the detection structure is adapted to detect, store, and transmit dose data representing the size of an expelled dose, 
 and wherein the drug device assembly further comprises 
 a receiving structure adapted to receive the transmitted dose data. 
 
     
     
       6. The drug delivery assembly according to  claim 3 ,
 wherein the detection structure is adapted to detect when the drug expelling mechanism has been actuated. 
 
     
     
       7. The drug delivery assembly according to  claim 1 , wherein the processor is further adapted to disregard a blood glucose value if the given blood glucose value corresponds to a blood glucose value outside a predefined range. 
     
     
       8. A drug delivery assembly comprising:
 (i) a memory structure adapted to receive data representing an initial basal insulin dosage regimen and fasting blood glucose values as a function of time over a period from m to n, wherein each of m and n is an integer representing a number of days; 
 (ii) a processor operatively connected to the memory structure and programmed to perform a titration process to obtain a new insulin titration dose; 
 wherein
     IU   Titration level ( n )= IU   Titration level ( n− 1)+Babystep( n ); 
   wherein 
   Babystep( n )= ISF   average ( n )*(Average FBG ( n )−Target FBG )* SF ( FBG   Variance ); and
 
 
 wherein
 IU Titration level (n) is the new insulin titration dose, 
 IU Titration level (n−1) is a previous insulin titration dose, 
 ISF average (n) is an average insulin sensitivity factor over the period from n−1 to n−m, 
 Average FBG (n) is an average fasting blood glucose over the period from n to n−m, 
 Target FBG  is a target fasting blood glucose level, and 
 SF(FBG Variance ) is a safety factor value that is a function of the variance of the fasting blood glucose, wherein the value is in the range of 0 to 1; and 
 
 (iii) an output structure adapted to communicate to the patient the new insulin titration dose; 
 (iv) an insulin reservoir or structure adapted to receive an insulin reservoir; 
 (v) an outlet for the insulin; 
 (vi) an insulin expelling mechanism adapted to expel the new titration insulin dose from the reservoir and out through the device; and 
 (vii) a detection structure adapted to detect when a patient-actuated operation is performed, wherein the operation is indicative of the administration of a dose of an insulin containing drug and is selected from the group consisting of:
 a cap-off event when the cap has been at least partially de-mounted from the drug delivery device for a pre-determined amount of time, 
 the size of an expelled dose, and 
 when the drug expelling mechanism has been actuated; 
 
 wherein the memory structure is further is adapted to receive data representing detected patient-actuated operations as a function of time; and 
 wherein the processor is further programmed to calculate a compliance value based on the detected patient-actuated operations compared to a pre-defined schedule for the patient-actuated operations. 
 
     
     
       9. The drug delivery assembly according to  claim 8 , wherein the patient-actuated operation is a cap-off event when the cap has been at least partially de-mounted from the drug delivery device for a pre-determined amount of. 
     
     
       10. The drug device assembly according to  claim 8 , wherein the patient-actuated operation is the size of an expelled dose. 
     
     
       11. The drug delivery assembly according to  claim 8 , wherein the patient-actuated operation is when the drug expelling mechanism has been actuated. 
     
     
       12. The drug delivery assembly according to  claim 8 , further comprising:
 a blood glucose meter structured to receive a patient blood sample and generate fasting blood glucose values as a function of time from patient blood samples; and 
 a transmission structure adapted to transmit the fasting blood glucose values as a function of time to the memory structure.